Introduction to the Validation of a Dissolution Apparatus

Abstract

Introduction Dissolution is defined as the process by which a known amount of drug substance goes into solution per unit of time under standardized conditions. The primary goal of dissolution testing is to be used as a qualitative tool to provide measurements of the bioavailability of a drug as well as to demonstrate bioequivalence from batch-to-batch. The bioavailability and bioequivalence data obtained as a result of dissolution testing can be used to guide the development of a new formulation and product development processes toward product optimization,as well as to ensure continuing product quality and performance of the manufacturing process. In addition,dissolution is a requirement for regulatory approval for product marketing and is a vital component of the overall quality control program (1). Dissolution testing is conducted using a dissolution apparatus that conforms to the specifications outlined in the United States Pharmacopeia. There are seven types of dissolution apparatus; the apparatus chosen to perform dissolution testing depends primarily on the drug dosage form. In order to have a high degree of assurance that the dissolution apparatus is consistent and accurate in its performance, validation is required. Validation is defined as documented evidence that provides a high degree of assurance that a specific instrument performs according to manufacturer’s specifications and user requirements. Validation is achieved by performing a series of validation activities; for a dissolution apparatus, validation is obtained through installation qualification and operational qualification.